Gene Therapy and Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin Lymphoma (NCT02337985)

🧪 Interventions in This Study

• Prednisone (DRUG)
• Rituximab (BIOLOGICAL)
• Etoposide (DRUG)
• Doxorubicin Hydrochloride (DRUG)
• Vincristine Sulfate (DRUG)
• Cyclophosphamide (DRUG)
• Filgrastim (BIOLOGICAL)
• Lentivirus Vector rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. HIV seropositive at or before the time of lymphoma diagnosis; all HIV positive patients are eligible regardless of HIV viral load or antiviral therapy (ART) status; all patients on study will receive ART as per standard guidelines
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
3. Biopsy proven lymphoma for which rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (R-EPOCH) is appropriate frontline therapy, e.g., Burkitt lymphoma or diffuse large B-cell lymphoma (DLBCL) NHL, including plasmablastic lymphoma and primary effusion lymphoma but not T-cell lymphoma; tissue histology will be reviewed at the treating institution
4. No psychosocial conditions that would hinder study compliance and follow-up
5. Pretreatment serum glutamic oxaloacetic transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT) =\< 2.5 x institutional upper limit of normal (ULN)
6. Pretreatment serum bilirubin =\< 2.5 x ULN or total bilirubin \< 4.5 mg/dl with direct fraction =\< 0.3 mg/dl in patients for whom these abnormalities are felt to be due to protease inhibitor therapy
7. Patients with evidence of hepatitis C virus (HCV) or hepatitis B virus (HBV) infection must have no clinical evidence of cirrhosis
8. Serum creatinine \< 2 x the institutional ULN; however, if serum creatinine \> 1.5 x ULN, a 24 hour urine creatinine clearance must be \> 50 ml/min unless there is renal involvement by lymphoma
9. Absence of clinically significant cardiomyopathy, congestive heart failure
10. If the subject is female and of child bearing potential, subject must have negative serum or urine pregnancy test within 7 days of treatment with research agent; men with partners of child-bearing potential and women of child-bearing potential must be willing to use medically effective birth control methods, e.g. contraceptive pill, condom, or diaphragm and continue this for one year post HSPC infusion
11. Subjects must be on a prophylactic regimen for Pneumocystis carinii pneumonia, or agree to begin such treatment and remain on treatment until after completion of therapy and until the cluster of differentiation (CD)4 cells are greater than 200/mm\^3
12. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for 12 months following stem cell infusion; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• NCI Lymphoid Malignancies Branch — Bethesda, Maryland

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All AIDS-Related Burkitt Lymphoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.